This document introduces the use of Agilent CE high sensitivity detection cell. Using this cell, ultra-low level impurity analysis of drug substances can be realized, and the impurity detection concentration can be as low as 0.1%
This document describes how capillary zone electrophoresis (CZE) combined with an Agilent high-sensitivity detection cell can detect and quantify drug impurities at levels below 0.1%. The technique is suitable for regulatory submissions requiring demonstration of purity in drug substances.
The text details the experimental setup using the Agilent Capillary Electrophoresis system, ChemStation software, and a specific high-sensitivity detection cell (part number G1600-68713). It presents data from an analysis of ranitidine impurities after shelf-life exposure to light.
| Detection Wavelength | 225/20 nm |
|---|---|
| Capillary Length | 56 cm eff (64.5) |
| Injection Pressure | 200 mbars |
| Run Temperature | 20 °C |
| Applied Voltage | 30 kV |
The analysis enables determination of impurities in drug substances below the 0.1 % area/area level.
The analysis enables the determination of impurities in drug substances below the 0.1 % area/area level.
The linear range over which the high-sensitivity cell operates is 2.2 AU.
The experiments utilized a capillary with an effective length of 56 cm and an internal diameter of 75 um.